- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274572
Blood for Immune Response to Provenge® in HRPC
April 6, 2015 updated by: Mary Crowley Medical Research Center
Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.
The trial only involves the collection of additional blood samples for the purposes of monitoring immune response.
These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T).
There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.
Description
Inclusion Criteria:
Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Response
Time Frame: Additional Blood Sample
|
Standard of Care Drug Immune Response
|
Additional Blood Sample
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Nemunaitis, MD, Mary Crowley Cancer Research Centers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
January 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
January 10, 2011
First Posted (Estimate)
January 11, 2011
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC 10-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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